Bioequivalence and Bioavailability Forum 01:17 CET

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What's the problem? [Regulatives / Guidelines]

posted by nobody - 2017-05-17 09:31  - Posting: # 17364
Views: 15,500

PS: No, I don't think that assay performance will do anything to intraindiv. CV of a drug product, as long as

- not practically all samples are around LLOQ
- effects are not random.

Did some sims in the old daysTM, effect of assay when validated according to current recommendations is negligible.

Especially for the "11% CV in 5 other trials, suddenly 40% in my trial" example there is no explanation remotely related to assay.

Kindest regards, nobody

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